The Dominican Republic has officially ordered a voluntary withdrawal of La Roche-Posay cosmetic products from the market, specifically the Effaclar 3 Step System and Effaclar Duo Benzoyl Peroxide Acne Treatment (1.35 FL.OZ), due to serious concerns regarding benzene contamination. This decision comes as the Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS) has been alerted to potential risks associated with the chemical.
On March 18, 2025, DIGEMAPS announced that the withdrawal is a precautionary measure prompted by the detection of benzene, a chemical classified as carcinogenic by the International Agency for Research on Cancer (IARC). Traces of benzene were specifically found in lot number MYX46W related to the Effaclar products. In response to these findings, L’Oréal USA, channeled through local distributor Oscar A. Renta Negrón, notified the health authorities of their decision to undertake this voluntary measure.
According to DIGEMAPS, the alert issued under code FVA-2025-0001 provides a 15-day deadline during which manufacturers and distributors must remove the affected products from the shelves of pharmacies across the Dominican Republic. Consumers are urged to cease any use of these products and to return them to their place of purchase.
The implications of benzene exposure are alarming, as the IARC has identified the chemical as carcinogenic in humans. Prolonged exposure can tragically lead to health issues such as leukemia and other serious blood disorders. "The IARC has determined that benzene is carcinogenic in humans," noted authorities in their official statement. With this in mind, precaution has become a priority for both consumers and health professionals.
The concerns are not isolated to the Dominican Republic; they stretch across international borders, notably impacting the U.S. market as well. Recent studies conducted by the FDA led to the withdrawal of numerous acne treatments—including products from reputable brands like Proactiv and Walgreens—when these tests revealed elevated levels of benzene in several similar items. The FDA alerted the public and industry about the tests conducted on 95 acne treatment products containing benzoyl peroxide, which may have been cross-contaminated with benzene.
This has caused a ripple of concern among consumers who use these products, with many questioning the safety of similar formulations. "The FDA has concluded that a number of products must be removed from retail settings," read the agency's alert.
While many such products are being pulled from shelves in the U.S., it's important to mention that the voluntary withdrawal of La Roche-Posay's Effaclar Duo with benzoyl peroxide applies exclusively to the United States. The formulation sold in countries like Peru is claimed to differ entirely, ensuring the absence of benzoyl peroxide and thus posing no similar risk.
The FDA has assured customers that the risk of developing cancer from these products, despite the findings, remains relatively low even with prolonged use. "Even with the daily use of these products for decades, the risk of a person developing cancer due to the exposure to benzene present in these products is very low," stated the regulatory body, attempting to calm public fears.
In a striking juxtaposition, local pharmacies in the Dominican Republic reported continued availability of the questioned products, as observed by Diario Libre during a recent tour across several establishments in the Distrito Nacional. Several pharmacies confirmed that not only were the products still on the shelves, but they also remained in stock, albeit in limited quantities.
Interactions with staff revealed a lack of clarity regarding the status of the Effaclar Duo Benzoyl Peroxide Acne Treatment. It was highlighted that while low quantities were noted, awareness of the health alert's implications varied among pharmacy employees. Some indicated they were unaware that the products were subject to withdrawal, although one staff member explicitly stated, "there is a health alert for this product due to benzene, which is harmful to health."
DIGEMAPS has reiterated the importance of adhering to the withdrawal and the necessity of reporting any adverse reactions experienced from the use of these products. The organization has set up dedicated channels for consumer feedback—including a phone line and email—to facilitate this communication.
The concerns regarding product safety, particularly those marketed for acne treatments, reflect growing consumer vigilance about personal care products. As watchdog bodies and companies strive to ensure safety standards, the withdrawal of La Roche-Posay products has surfaced as a significant step in addressing public health concerns and fostering trust in cosmetic safety. Appeals have been made not just to remove dangerous products but also to maintain transparency in consumer communications.
This incident serves as a critical reminder of the need for consumers to remain informed and proactive regarding the products they use. In the end, the commitment of both health authorities and manufacturers must ensure that product safety checks become more stringent to prevent future incidents.
